Telangana Drug Control Administration Cancels Mylan Laboratories’ License Over Unauthorized Diversion of Alprazolam
Hyderabad, Feb 14: The Drug Control Administration (DCA) of Telangana has revoked the manufacturing license of pharmaceutical giant Mylan Laboratories for Alprazolam after detecting unauthorized diversion of the psychotropic substance from its facility near Hyderabad.
According to DCA officials, the unapproved diversion of 21.250 kilograms of Alprazolam from Mylan Laboratories Ltd., Unit-7, by certain employees acting as chemists and production officers was discovered by Prohibition & Excise authorities. Prohibition & Excise officials seized 4.850 kilograms of Alprazolam from the consumables room of Mylan’s unit in Pashamylaram, Patancheru mandal, Sangareddy district.
DCA Director General V.B. Kamalasan Reddy stated that the unauthorized diversion event, which posed a risk of Alprazolam abuse, was brought to their attention by Excise authorities. Following an inspection and issuance of a show cause notice to Mylan Laboratories Unit-7, the firm failed to notify DCA regarding the diversion and address reported violations.
Considering the severity of the violations related to the psychotropic substance Alprazolam and its unauthorized diversion, the manufacturing license has been canceled with immediate effect in the public interest, said the Director General.
Mylan was licensed by DCA Telangana to produce Alprazolam (Active Pharmaceutical Ingredient) and supply exclusively to formulation manufacturing units.
Alprazolam is a psychotropic substance under the Narcotic Drugs and Psychotropic Substances Act (NDPS Act), used for treating anxiety and panic disorders. Its misuse can lead to addiction, physical dependence, and withdrawal symptoms. The DCA emphasized the need for stringent measures by manufacturers to prevent unauthorized diversion, pilferage, or theft.
Surprise raids will be intensified on manufacturing units holding licenses for narcotic drugs and psychotropic substances to ensure compliance and take legal action against violators, the DG added.
